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Adjuvant Therapy for Endometrial Cancer (RAINBO Trial)

Phase 2 & 3

Recruiting

Led By Judith R Kroep, MD PhD

Research Sponsored by Leiden University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Underwent hysterectomy and bilateral salpingo-oophorectomy without macroscopic residual disease

WHO performance status 0, 1 or 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years, 5 years

Awards & highlights

RAINBO Trial Summary

This trial is for endometrial cancer patients with different molecular profiles. They will be assigned to different trials based on their profile and will receive different adjuvant therapies.

Who is the study for?

This trial is for patients with endometrial cancer, categorized by their cancer's molecular profile. They must have a WHO performance status of 0-2, weigh over 30 kg, and have no distant metastases or major surgeries within the last 28 days. Patients should not have had prior treatments that conflict with the trial drugs and must be able to follow up for treatment.Check my eligibility

What is being tested?

The RAINBO program includes four trials testing new adjuvant therapies in endometrial cancer based on molecular profiles: p53abn-RED for p53 abnormal cancers; MMRd-GREEN for mismatch repair deficient; NSMP-ORANGE when there's no specific profile; POLEmut-BLUE for POLE mutant cancers.See study design

What are the potential side effects?

Potential side effects may include reactions related to chemotherapy, immunotherapy (like Durvalumab), hormonal therapy (such as Medroxyprogesterone Acetate), targeted therapy (Olaparib), radiation therapy, and observation-related complications. Specifics depend on each patient's treatment plan.

RAINBO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had my uterus and both ovaries removed with no visible disease left.

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I can take care of myself but may not be able to do heavy physical work.

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My endometrial cancer diagnosis is confirmed by tissue analysis.

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My cancer has not spread to distant parts of my body.

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I will start treatment within 10 weeks after my surgery.

RAINBO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years, 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years, 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years, 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

MMRd-GREEN trial

NSMP-ORANGE trial

POLEmut-BLUE trial

+1 more

Secondary outcome measures

Endometrial cancer-specific survival

Health-related quality of life - Assessed using the EORTC QLQ-C30 questionnaire

Health-related quality of life - Assessed using the EORTC QLQ-EN24 questionnaire

+5 more

Side effects data

From 2014 Phase 4 trial • 45 Patients • NCT02000531

29%

Nausea

19%

Leukopenia

14%

White blood cell count decreased

14%

Vomiting

14%

Thrombocytopenia

14%

Alanine aminotransferase increased

14%

Anaemia

14%

Neutropenia

10%

Neutrophil count decreased

10%

Platelet count decreased

10%

Aspartate aminotransferase increased

Dizziness

Back pain

Diarrhea

Musculoskeletal pain

100%

80%

60%

40%

20%

Study treatment Arm

Erlotinib-Chemotherapy

Chemotherapy-Erlotinib

RAINBO Trial Design

8Treatment groups

Experimental Treatment

Active Control

Group I: p53abn-RED trial: experimentalExperimental Treatment4 Interventions

Adjuvant radiotherapy and chemotherapy followed by olaparib (lynparza), 300 mg twice daily, for two years

Group II: POLEmut-BLUE trial: main cohortExperimental Treatment1 Intervention

No adjuvant therapy in women with: stage IA (not confined to polyp), grade 3, pN0, with or without LVSI stage IB, grade 1 or 2, pNx/N0, with or without LVSI stage IB, grade 3, pN0, without substantial LVSI stage II (microscopic), grade 1 or 2, pN0, without substantial LVSI

Group III: POLEmut-BLUE trial: exploratory cohortExperimental Treatment3 Interventions

No adjuvant therapy or vaginal brachytherapy or pelvic external beam radiotherapy in women with: stage IA (not confined to polyp), grade 3, pNx, with or without LVSI stage IB, grade 3, pNx, with or with LVSI. stage IB, grade 3, pN0, with substantial LVSI. stage II (microscopic), grade 1 or 2, pNx, with or without LVSI. stage II (microscopic), grade 1 or 2, pN0, with substantial LVSI. stage II (microscopic), grade 3, pNx/N0, with or without LVSI. stage II non-microscopic, any grade, pNx/N0, with or without LVSI. stage III, any grade, pNx/N0-2, with or without LVSI.

Group IV: NSMP-ORANGE trial: experimentalExperimental Treatment4 Interventions

Adjuvant radiotherapy followed by oral progestagens (medroxyprogesterone acetate or megestrol acetate) for two years

Group V: MMRd-GREEN trial: experimentalExperimental Treatment3 Interventions

Adjuvant radiotherapy combined with and followed by durvalumab, 1500 mg intravenous once every 4 weeks for in total 1 year (13 cycles)

Group VI: MMRd-GREEN trial: controlActive Control2 Interventions

Adjuvant pelvic external beam radiotherapy

Group VII: NSMP-ORANGE trial: controlActive Control3 Interventions

Adjuvant radiotherapy and chemotherapy

Group VIII: p53abn-RED trial: controlActive Control3 Interventions

Adjuvant radiotherapy and chemotherapy

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Medroxyprogesterone Acetate

2019

Completed Phase 3

~530

Chemotherapy

2003

Completed Phase 4

~3050

Durvalumab

2017

Completed Phase 2

~3870

Megestrol Acetate

2007

Completed Phase 3

~540

Olaparib

2007

Completed Phase 4

~2140

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University College London (sponsor NSMP-ORANGE trial)UNKNOWN

AstraZenecaIndustry Sponsor

4,271 Previous Clinical Trials

288,611,081 Total Patients Enrolled

10 Trials studying Endometrial Cancer

2,196 Patients Enrolled for Endometrial Cancer

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,345 Previous Clinical Trials

26,451,952 Total Patients Enrolled

2 Trials studying Endometrial Cancer

1,250 Patients Enrolled for Endometrial Cancer

Media Library

Chemotherapy Clinical Trial Eligibility Overview. Trial Name: NCT05255653 — Phase 2 & 3

Endometrial Cancer Research Study Groups: MMRd-GREEN trial: control, NSMP-ORANGE trial: control, POLEmut-BLUE trial: main cohort, NSMP-ORANGE trial: experimental, MMRd-GREEN trial: experimental, POLEmut-BLUE trial: exploratory cohort, p53abn-RED trial: experimental, p53abn-RED trial: control

Endometrial Cancer Clinical Trial 2023: Chemotherapy Highlights & Side Effects. Trial Name: NCT05255653 — Phase 2 & 3

Chemotherapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05255653 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients are enrolled in this research?

"That is correct. The information available on clinicaltrials.gov reveals that this clinical study is looking for volunteers. The trial was first posted on 2021-11-11 and has since been edited on 2022-10-18. They are admitting 1611 participants from 2 different sites."

Answered by AI

Are new patients being accepted into the research at this time?

"That is correct, the information available on clinicaltrials.gov suggests that this trial is still recruiting patients. The trial was created on November 11th, 2021 and was last edited on October 18th, 2022. The study needs 1611 participants from 2 different sites."

Answered by AI

What are the researchers' goals for this clinical trial?

"The purpose of this 3-year clinical trial, known as the NSMP-ORANGE trial, is to...? Secondary outcomes being tracked include health-related quality of life, recurrence-free survival, and endometrial cancer-specific survival."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features

Carien Creutzberg 2021. "Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05255653.